•  
  •  
 

Abstract

Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System since the 2010 issuance of ICH Q10. Yet these disciplines have remained largely distinct and disconnected in practice. This paper presents a two-part literature review on this topic. First is a review of how other industries have connected risk management and knowledge management. This is followed by a review of relevant biopharmaceutical industry regulatory guidance to explore expectations for how risk, risk management, knowledge and knowledge management are interdependent. The results suggest there is a strong argument in favor of linking risk management and knowledge management and other industries have demonstrated benefits in doing so. Furthermore, the review of the biopharmaceutical industry regulatory guidance shows the clear and persistent benefits of connecting the expectations of managing risk and knowledge together. A key conclusion is that risk varies inversely with knowledge application and therefore, a lower level of risk to quality (and ultimately to the patient) can be achieved through risk management practices when a thoughtful and programmatic approach to knowledge management is in place, providing the best possible knowledge to assess and control risk.

DOI

https://doi.org/10.21427/2jdq-jq09

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

Share

COinS
 
 

To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.